2017/0046/IRL
EC/EFTA
IE Irland
  • C10P - Pharmazeutische Produkte
N/A
2017-02-14

The draft Misuse of Drugs Regulations 2017 apply varying levels of controls to the groups of drugs specified in Schedules 1 to 5 of the Regulations. The substances are already subject to control under the Misuse of Drugs Acts, 1977 to 2016, but the Regulations set out the extent of such control.

The effect of the Regulations is to impose restrictions on the production, supply, importation and exportation of the drugs in question, which vary according to the extent to which these drugs are used for medical or scientific purposes and having regard to the likelihood of their being abused. Appropriate exemptions are provided to cover legitimate use for professional purposes by doctors, pharmacists, nurses and midwives, veterinary surgeons, prison officers, etc. and in other specified circumstances.

In addition to these controls the Regulations specify the classes of persons who may have controlled drugs in their possession and the circumstances in which such possession would not be in contravention of the Acts.

The Regulations contain other miscellaneous provisions such as requirements as to the form of prescriptions for controlled drugs, the keeping of books and records, proper documentation relating to export of controlled drugs, arrangements for destruction or disposal of such drugs, and provisions regarding possession of forged prescriptions.

The substances to be controlled include those which Ireland is required to subject to national control on foot of obligations under the EU Council Decision 2005/387/JHA of 10 May 2005 on information exchange, risk assessment and control of new psychoactive substances, and of obligations as a party to the United Nations Conventions on Narcotic Drugs 1961 and Psychotropic Drugs 1971: Phenazepam, 25B-NBOMe, 25C-NBOMe, MT-45, and 4,4’-DMAR.

In addition a number of other new psychoactive substances, known to be misused in Ireland, are controlled: 5F-AKB-48 and 5F-PB-22 (synthetic cannabinoids associated with the pyschoactive substance known as “Clockwork Orange”); and MDMB-CHMICA.

Finally some medicinal products are subjected to control under the Regulations: Zopiclone, Zaleplon and Lisdexamfetamine, whilst controls on a specific form of extract of cannabis with a marketing authorisation, containing limited amounts of cannabidiol to delta-9-tetrahydrocannabinol within a narrow ratio, and presented as a specific formulation, will be lessened.

Proposed Orders and Regulations under the Misuse of Drugs Acts 1977 to 2016, to amend the level of control placed upon certain substances; to control a number of additional substances; and related matters.

The proposed Misuse of Drugs Regulations 2017 will replace the existing Misuse of Drugs Regulations which were made in 1988 and amended a number of times since then. The proposed 2017 Regulations will update outmoded references in the 1988 Regulations. In addition, the 2017 Regulations will insert each substance listed above in Section 6 into the Schedules to the Misuse of Drugs Regulations, depending on the legitimate use of the substance, its potential for misuse and extent of controls necessary to protect the public. Finally, the 2017 Regulations will amend the level of control which currently applies to benzodiazepine substances by making it an offence for a person to be in possession of them without proper authority, such as an import licence or a Misuse of Drugs prescription.

Schedule 1 contains a list of controlled drugs which have no medicinal use and consequently the production, import, export, supply and possession of these substances is prohibited. It is proposed to insert 25B-NBOMe, 25C-NBOMe, MT-45, 4,4’-DMAR, 5F-AKB-48, 5F-PB-22 and MDMB-CHMICA in to Schedule 1 to the Regulations.

The other substances which are medicines but have the potential to be misused, are inserted into Schedules 2 and 4, permitting production, import and export in accordance with a licence, and placing controls on their supply and possession.

The Misuse of Drugs (Designation) Order 2017 will include the substances to be inserted into Schedule 1 of the Misuse of Drugs Regulations , as substances for which the manufacture, production, preparation, sale, distribution or possession is wholly unlawful, or unlawful except for research or special purposes and only in accordance with a licence.

The Misuse of Drugs (Exemption) Order 2017 will include substances which are controlled under the Misuse of Drugs Acts but in relation to which possession is not provided for in the Regulations, and consequently in relation to which there is no offence of possession. These are primarily low-dosage preparations and certain plants indigenous to Ireland where these grow uncultivated.